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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K903022
Device Name FIXATION STAPLE
Applicant
Onyx Medical Corp.
152 Collins St.
Memphis,  TN  38112
Applicant Contact GEORGE W MURRAY
Correspondent
Onyx Medical Corp.
152 Collins St.
Memphis,  TN  38112
Correspondent Contact GEORGE W MURRAY
Regulation Number888.3030
Classification Product Code
JDR  
Date Received07/10/1990
Decision Date 08/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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